Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

Device Description

The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.

Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.

However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:

Device: Surgical Gown (Model 40083)
Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.

Acceptance Criteria and Reported Device Performance:

Test Item	Test Standard	Acceptance Criteria	Reported Device Performance (Result)
Seam Strength	ASTM D1683M-17	≥30N (7lbf) per standard F2407-20 for Level 3	PASS: 68.46 N (Average result from 30 samples)
Breaking Strength	ASTM D5034-09 (2017)	≥30N (7lbf) per standard F2407-20 for Level 3	PASS: MD: 120.61N, CD: 88.19N (Average result from 30 samples)
Tear Strength (N)	ASTM D5587-15	≥20N	PASS: MD: 60.03N, CD: 39.78N (Average result from 30 samples)
Lint and other generation in the dry state	ISO 9073-10:2003(E)	Log10(particle count) < 4	PASS: 1.9 (Average result from 6 samples)
Flammability	CPSC 16 CFR Part 1610-2008	Class I	PASS: Class I
Water Penetration Resistance (Impact)	AATCC 42-2013	≤1.0g AQL: 4% Level 3 per ANSI/AAMI PB70:2012	PASS: ≤1.0g
Static Hydrostatic Resistance	AATCC 127-2014	≥50 cmH2O per ANSI/AAMI PB70:2012 for Level 3	PASS: ≥50 cm
EO and ECH sterilization residual	ISO 10993-7:2008	EO ≤ 4mg/d, ECH ≤ 9mg/d	PASS: EO ≤ 4mg/d, ECH ≤ 9mg/d
Cytotoxicity	ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Non-Cytotoxic	PASS: Under the conditions of the study, the device is non-cytotoxic.
Irritation	ISO 10993-23 (Biological evaluation of medical devices - Part 23: Tests for irritation)	Non-Irritating	PASS: Under the conditions of the study, the device is non-irritating.
Sensitization	ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Sensitization)	Non-Sensitizing	PASS: Under the conditions of the study, the device is non-sensitizing.

Details Regarding the Study:

Sample sizes used for the test set and the data provenance:
- Seam Strength, Breaking Strength, Tear Strength: "Average result from 30 samples" for each test.
- Lint and other generation: "Average result from 6 samples."
- Water Penetration Resistance, Static Hydrostatic Resistance, EO/ECH Residual, Cytotoxicity, Irritation, Sensitization, Flammability: The specific number of samples for these tests is not explicitly stated as "X samples" in the provided text, but the results are reported as "PASS," indicating that the required sample sizes for the respective standards were met.
- Data Provenance: The document does not specify the country of origin for the testing data (e.g., in-house testing by the manufacturer's lab in China, or third-party labs). The submission is from Ammex-Weida (Hubei) Health and Safety Products Co., Ltd in China. All studies described are non-clinical, laboratory-based tests. They are not categorized as retrospective or prospective clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/SaMD product requiring expert-derived ground truth for diagnostic accuracy. The "ground truth" here is defined by the objective physical and chemical standards and their corresponding test methods (e.g., AATCC, ASTM, ISO).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/SaMD product. The results are from standardized laboratory tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/SaMD product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/SaMD product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by internationally recognized industry standards and test methods (e.g., ANSI/AAMI PB70:2012 for barrier performance, ASTM for material strength, ISO for biocompatibility, etc.). These standards define the quantitative and qualitative acceptance criteria for the device's physical safety and performance.
The sample size for the training set:
- Not applicable, as this is not an AI/SaMD product that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as this is not an AI/SaMD product that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 1, 2024

Ammex-Weida (Hubei) Health and Safety Products Co., Ltd % Jarvis Wu Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K233183

Trade/Device Name: Surgical Gown (40083) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 29, 2023 Received: December 29, 2023

Dear Jarvis Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233183

Device Name

Surgical Gown (40083)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary K233183

Document prepared date: 2024/1/30

A. Applicant:

Name: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Address: Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei China, 433011 Contact Person: Melody Wang Tel: +86 13476816925 Mail: office@hborient.com

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122. China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050

Email: zxfda@sungoglobal.com

B. Device:

Trade Name: Surgical Gown Common Name: Surgical Gown Model(s): 40083

Regulatory Information Classification Name: Gown. Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K231510 Surgical Gown XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD

D. Intended use /Indications for Use:

Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

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E. Device Description:

The proposed devices are disposable medical devices and provided in sterile and blue color.

Table 1 General Comparison
Device	Proposed Device	Predicate Device	Remark
Manufacturer	Ammex-Weida (Hubei) Health andSafety Products Co., Ltd	XIANTAO ZHIBO NON-WOVENPRODUCTS CO.,LTD.	-
510K number	K233183	K231510	-
ProductName	Surgical Gown	Surgical Gown	Same
Classification	Class II Device, FYA (21CFR878.4040)	Class II Device, FYA(21CFR878.4040)	Same
Intended use/Indicationsfor Use	Surgical Gowns are intended to beworn by operating room personnelduring surgical procedures to protectthe surgical patient and operatingroom personnel from the transfer ofmicroorganisms, body fluids andparticulate material. This surgicalgown meets the requirements ofAAMI Level 3 barrier protection fora surgical gown per ANSI/AAMIPB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapesintended for use in health carefacilities (AAMI PB70). TheSurgical Gowns are single use,disposable medical devices,provided sterile.	Surgical Gown is intended to beworn by room personnel duringsurgical procedures or other invasivetests to protect both the surgicalpatient and operating roompersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. This is singleuse, disposable device, providedsterile.Per ANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protective appareland drapes intended for use in healthcare facilities, the Surgical Gownmet the requirements for Level 3classification.	Same
Style	Non-reinforced	Non-reinforced	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Item	Proposed Device(K233183)	Predicate Device(K231510)	Remark
Size	XS, S, M, L, XL, 2XL, 3XL	S, M, L, XL, XXL, XXXL	Different.resolved byperformancetesting
Weight persquare(g)	45 g/m2	50 g/m2	Different.No affect onsafety orefficacy
HydrostaticPressure(cm)AATCC-127	>50 cm	>50 cm	Same
Water impactAATCC-42	≤1.0 g	≤1.0 g	Same
Breakingstrength	MD: 120.61NCD: 88.19N	MD: 144.87NCD: 88.89N	Similar
Tearingstrength	MD: 60.03NCD: 39.78N	MD: 69.61NCD: 32.25N	Similar
SeamStrength	>30N	>30N	Same
Flammability	Class I	Class I	Same
EO residue	EO ≤ 4mg/dECH ≤ 9mg/d	EO ≤ 4mg/dECH ≤ 9mg/d	Same
Shelf life	3 years	3 years	Same
Barrierprotection level	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Material	SSMMS non-woven, Cotton,and Nylon + polyester	SMMS non-woven, Cotton, and Nylon	Different
Biocompatibility	Under the conditions of the study, the device extract was not cytotoxic.Under the conditions of the study, the non-polar and polar deviceextracts were not found to be an irritant.Under conditions of the study, the non-polar and polar deviceextracts were not found to be a sensitizer.		Same

F. Comparison with predicate device Table 1 General Comparison

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Table 2 Safety and Performance Comparison

Analysis

The weight per square (g) ,size and material are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard.

Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the material. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier

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Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

G. Summary of Non-Clinical Tests

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.

Test Item	Test standard	Acceptance Criteria	Result
Seam strengthASTM D1683M-17 Standard TestMethod forFailure in SewnSeams of WovenFabrics.	The test was performedIn accordance withASTM D1683M-17Standard. Test Methodfor Seam Strength ofTextile Fabrics (GrabTest) to evaluate Failurein Sewn Seams of the testsample.	≥30N(7lbf)per standardF2407-20 for level 3	PASS68.46 N(Average result from 30samples)
BreakingstrengthASTM D5034-09(2017)Standard TestMethod forBreaking Strengthand Elongation ofTextile Fabrics(Grab Test)	The test was performedIn accordance withD5034-09 (2017) .Standard. Test Methodfor Breaking Strengthand Elongation of TextileFabrics (Grab Test) toevaluate the breakingstrength of the testsample.	≥30N(7lbf)per standardF2407-20 for level 3	PASSMD: 120.61NCD: 88.19N(Average result from 30samples)
Tear strength(N)ASTM D5587-15,Standard TestMethod forTearing Strengthof Fabrics byTrapezoidProcedure	The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method for TearingStrength of Fabrics byTrapezoid Procedure toevaluate the tearingstrength of the testsample.	≥20N	PASSMD: 60.03NCD: 39.78N(Average result from 30samples)
Lint and othergeneration in thedry stateISO 9073-10:2003(E)	The test was performedin accordance with ISO9073-10: 2003 Textiles-Test Methods forNonwovens-Part 10: Lintand Other ParticlesGeneration in the DryState to evaluate thelinting of the test sample.	Log10(particle count)< 4	PASS1.9(Average result from 6samples )
FlammabilityCPSC 16 CFR	The test was performedin accordance with 16	Class I	PASS
Part1610-2008,Standard for theFlammability ofclothing textiles	CFR Part 1610 Standardfor the Flammability ofClothing Textiles toevaluate the flammabilityof the test sample.		Class I
WaterPenetrationResistanceAATCC 42-2013,ImpactPenetration Test	The test was performedin accordance withAATCC 42: 2013Water Resistance: ImpactPenetration Test toevaluate the water impactof the test sample.	≤1.0g AQL: 4%Level 3 per standardANSI/AAMIPB70:2012 for level 3	PASS≤1.0g
StatichydrostaticresistanceAATCC 127-2014,Water Resistance:HydrostaticPressure Test;	The test was performedin accordance withAATCC 127: 2014Water Resistance:Hydrostatic Pressure Testto determine thehydrostatic pressure ofthe test sample.	≥50 cmH2O perstandard ANSI/AAMIPB70:2012 for level 3	PASS≥50 cm
EO and ECHsterilizationresidualISO 10993-7:2008Ethylene oxidesterilizationresiduals	The test was performedin accordance with ISO10993-7:2008 Ethyleneoxide sterilizationresiduals to determine theEO and ECH residuals ofthe test sample.	EO ≤ 4mg/dECH ≤ 9mg/d	PASSEO ≤ 4mg/dECH ≤ 9mg/d
CytotoxicityISO 10993-5Biologicalevaluation ofmedical devices- Part 5: Testsfor in vitrocytotoxicity	The test was performedin accordance with ISO10993-5 to determinecytotoxicity of the testsample	Non-Cytotoxic	PASSUnder the conditions of thestudy, the device is non-cytotoxic.
IrritationISO 10993-23Biologicalevaluation ofmedical devices -Part 23: Tests forirritation	The test was performedin accordance with ISO10993-23 to determineIrritation of the testsample	Non-Irritating	PASSUnder the conditions of thestudy, the device is non-irritating.
SensitizationISO 10993-10BiologicalEvaluation ofMedical Devices -Part 10: Tests ForSensitization	The test was performedin accordance with ISO10993-10 to determineskin sensitization of thetest sample	Non-Sensitizing	PASSUnder the conditions of thestudy, the device is non-sensitizing

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Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei,China, 433011

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H. Summary of Clinical Test

No clinical study is included in this submission.

I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device proposed in this 510(k) is safe, as effective, and performs as well as or better than the legally marketed predicate device under K231510.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.